Diabetes Mellitus, Type 2 With Acute Coronary SyndromNCT04354740
Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
An observational study of Diabetes Mellitus, Type 2 With Acute Coronary Syndrom, run by Assiut University.
Trial summary
To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS. To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 With Acute Coronary Syndrom
- What is being tested?
- with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) Those patients are divided to: Group A : Diabetic Group B: Non diabetic Then each group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
Who may be able to join
- This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) from July 2020 to June2021 in both CCU Of Internal Medicine Departemennt and and EL Orman Assiut University Hospital of Cardiology and Cardiothoracic Surgery.
- ACS was defined and patients were managed according to the European Guidelines . Patients with acute chest pain and persistent (>20 min) ST-segment elevation, i.e., STEMI generally reflected an acute total coronary occlusion. All patients received immediate myocardial reperfusion treatment by primary coronary intervention and angioplasty or fibrinolytic therapy, as appropriate. Patients with acute chest pain but no persistent ST-segment elevation, referred to as Non-STEMI included transient ST-segment elevation, persistent or transient ST-segment depression ,T-wave inversion, flat T waves or pseudo-normalized T waves or completely normal ECG at admission. Thygesen, K.; etal.2019
Who cannot join
- -Ranal disease ie stage 3,4 or on dialysis.
- Advanced hepatic diseases ie(child B,C)
- Poor echo window including morbid obesity.
- Age >18 and more than 55 years old
- Patients with previous history of significant valvular diseases,atrial fibrillation
- EF less than 40%
Trial locations and contacts
No sites are listed yet.
About this study
- To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS.
- To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities.
Read the detailed description
Diabetes mellitus (DM) doubles the risk of cardiovascular disease and about 75% of deaths in diabetic patients are due to coronary artery disease. Studies performed during the 1980's and 90's demonstrated increasing short and long-term mortality in diabetic patients undergoing CABG compared with non-diabetic patients. However, more recently, reports have shown a significant reduction in mortality among patients with diabetes. Alexander Kogan etal., 2018 Cardiac revascularization in patients with stable coronary artery disease (CAD) is an important therapeutic intervention for the improvement of symptoms and prognosis. Prior to revascularization, patients must receive guideline-recommended medical therapy due to its established benefits. Thomas Nyström etal.,2018 Also notable is that the best current revascularization results achieved with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES) and for coronary artery bypass grafting (CABG) with maximal use of arterial grafts. The multitude of studies for revascularization comparing PCI and CABG cannot provide a single solution for the entire spectrum of patients with stable CAD. Nevertheless, CABG results in more complete revascularization than PCI, particularly in complex multivessel CAD, which often is observed in patients with diabetes. Thomas Nyström etal., 2018 Approximately 25% of all patients who undergo multivessel revascularization have diabetes. A number of studies have demonstrated that CABG should be the preferred strategy for multivessel revascularization in patients with diabetes. In this group, CABG leads to improved survival rates and a reduced risk of myocardial infarction and repeat revascularization compared with revascularization with PCI. In the BARI (Bypass Angioplasty Revascularization Investigation) trial, a subset of 353 patients with diabetes who underwent PCI had almost a doubled 5-year mortality compared with those who underwent CABG. However, if only saphenous vein grafts were used as conduits, cardiac mortality was similar to that with PCI, demonstrating the importance of arterial grafting. It was further demonstrated in the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) study that among patients with diabetes, prompt revascularization by CABG significantly reduced major CV events compared with intensive medical treatment alone. In contrast, there was no difference in CV events between patients who underwent PCI and patients who received only intensive medical treatment.Thomas Nyström etal.,2018 Pathological left ventricular remodeling (LVR) was the common characteristic of most cardiovascular diseases. It clinically defined as the adverse changes in LV mass, volume, and geometry after myocardial injury, which could be considered to be an adaptive response to cardiac performance inadequacy and a marker of poor prognosis in patients with underlying LV dysfunction. In recent years, the impact of non hemodynamic factors on cardiac structure and function, such as obesity and other metabolic disorder, had been gradually valued. Van Bilsen et al even proposed a theory of "metabolic remodeling." This theory held that glycolipid metabolism disturbance could change the metabolic pathway of myocardial energy and finally lead to LV remodeling and dysfunction. Qingqing Wang etal.,2018 Myocardial strain quantification by speckle tracking echocardiography has been well validated. It is a validated and accurate measure of regional systolic LV function.It has also been shown to be superior to visual assessment of wall motion in detection and quantification of regional systolic function. Strain and other deformation parameters are sensitive tools for detection of ischemia. It is hypothesized that global and regional left ventricular2D strain by speckle tracking echocardiography (STE) facilitates an early and accurate non-invasive tool to predict the presence of acute coronary artery occlusion in patients with non ST-segment elevation myocardial infarction (NSTEMI). Viola William Keddeas,etal 2016
- Being tested
- with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)Procedure or surgery
Also called coronary artery bypass grafting (CABG) with maximal use of arterial grafts
II-PCI:
-Coronary angiography and intervention will be done according to the European guidelines of ACS revascularization.
III-CABG:
| Study group | Role | What they receive |
|---|---|---|
| Group A : Diabetic | group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study Receives: Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES) | |
| Group B: Non diabetic | group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study Receives: Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACEs)
Rate of myocardial infarction (MI), Rate of revascularization, Rate of cerebrovascular events"stroke"
Measured: 12 mounths
Secondary outcomes (1)
In hospital mortality
Rate of death (mortality rate)after CABG or PCI
Measured: 12mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2 With Acute Coronary SyndromStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Emad Ahmed Mohmed Mashhour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354740
- Sponsor's protocol ID
- coronary revascularization,DM2
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patel SA, Deepa M, Shivashankar R, Ali MK, Kapoor D, Gupta R, Lall D, Tandon N, Mohan V, Kadir MM, Fatmi Z, Prabhakaran D, Narayan KMV. Comparison of multiple obesity indices for cardiovascular disease risk classification in South Asian adults: The CARRS Study. PLoS One. 2017 Apr 27;12(4):e0174251. doi: 10.1371/journal.pone.0174251. eCollection 2017.
PubMed 28448582Lu H, Tang B, Zhou Y, Xu C, Bundhun PK, Tang Z, Bao H. Short-Term Versus Long-Term Adverse Cardiovascular Outcomes Post Percutaneous Coronary Intervention in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Simple Meta-Analysis. Diabetes Ther. 2019 Aug;10(4):1487-1497. doi: 10.1007/s13300-019-0656-9. Epub 2019 Jun 29.
PubMed 31256352
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04354740
- Acronym / sponsor ID
- coronary revascularization,DM2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS.
- To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities.
Detailed description
Diabetes mellitus (DM) doubles the risk of cardiovascular disease and about 75% of deaths in diabetic patients are due to coronary artery disease. Studies performed during the 1980's and 90's demonstrated increasing short and long-term mortality in diabetic patients undergoing CABG compared with non-diabetic patients. However, more recently, reports have shown a significant reduction in mortality among patients with diabetes. Alexander Kogan etal., 2018 Cardiac revascularization in patients with stable coronary artery disease (CAD) is an important therapeutic intervention for the improvement of symptoms and prognosis. Prior to revascularization, patients must receive guideline-recommended medical therapy due to its established benefits. Thomas Nyström etal.,2018 Also notable is that the best current revascularization results achieved with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES) and for coronary artery bypass grafting (CABG) with maximal use of arterial grafts. The multitude of studies for revascularization comparing PCI and CABG cannot provide a single solution for the entire spectrum of patients with stable CAD. Nevertheless, CABG results in more complete revascularization than PCI, particularly in complex multivessel CAD, which often is observed in patients with diabetes. Thomas Nyström etal., 2018 Approximately 25% of all patients who undergo multivessel revascularization have diabetes. A number of studies have demonstrated that CABG should be the preferred strategy for multivessel revascularization in patients with diabetes. In this group, CABG leads to improved survival rates and a reduced risk of myocardial infarction and repeat revascularization compared with revascularization with PCI. In the BARI (Bypass Angioplasty Revascularization Investigation) trial, a subset of 353 patients with diabetes who underwent PCI had almost a doubled 5-year mortality compared with those who underwent CABG. However, if only saphenous vein grafts were used as conduits, cardiac mortality was similar to that with PCI, demonstrating the importance of arterial grafting. It was further demonstrated in the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) study that among patients with diabetes, prompt revascularization by CABG significantly reduced major CV events compared with intensive medical treatment alone. In contrast, there was no difference in CV events between patients who underwent PCI and patients who received only intensive medical treatment.Thomas Nyström etal.,2018 Pathological left ventricular remodeling (LVR) was the common characteristic of most cardiovascular diseases. It clinically defined as the adverse changes in LV mass, volume, and geometry after myocardial injury, which could be considered to be an adaptive response to cardiac performance inadequacy and a marker of poor prognosis in patients with underlying LV dysfunction. In recent years, the impact of non hemodynamic factors on cardiac structure and function, such as obesity and other metabolic disorder, had been gradually valued. Van Bilsen et al even proposed a theory of "metabolic remodeling." This theory held that glycolipid metabolism disturbance could change the metabolic pathway of myocardial energy and finally lead to LV remodeling and dysfunction. Qingqing Wang etal.,2018 Myocardial strain quantification by speckle tracking echocardiography has been well validated. It is a validated and accurate measure of regional systolic LV function.It has also been shown to be superior to visual assessment of wall motion in detection and quantification of regional systolic function. Strain and other deformation parameters are sensitive tools for detection of ischemia. It is hypothesized that global and regional left ventricular2D strain by speckle tracking echocardiography (STE) facilitates an early and accurate non-invasive tool to predict the presence of acute coronary artery occlusion in patients with non ST-segment elevation myocardial infarction (NSTEMI). Viola William Keddeas,etal 2016
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Diabetic | – | Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study |
| Group B: Non diabetic | – | Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) Those patients are divided to: Group A : Diabetic Group B: Non diabetic Then each group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
Key inclusion criteria (2 listed)
- This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) from July 2020 to June2021 in both CCU Of Internal Medicine Departemennt and and EL Orman Assiut University Hospital of Cardiology and Cardiothoracic Surgery.
- ACS was defined and patients were managed according to the European Guidelines . Patients with acute chest pain and persistent (>20 min) ST-segment elevation, i.e., STEMI generally reflected an acute total coronary occlusion. All patients received immediate myocardial reperfusion treatment by primary coronary intervention and angioplasty or fibrinolytic therapy, as appropriate. Patients with acute chest pain but no persistent ST-segment elevation, referred to as Non-STEMI included transient ST-segment elevation, persistent or transient ST-segment depression ,T-wave inversion, flat T waves or pseudo-normalized T waves or completely normal ECG at admission. Thygesen, K.; etal.2019
Key exclusion criteria (6 listed)
- -Ranal disease ie stage 3,4 or on dialysis.
- Advanced hepatic diseases ie(child B,C)
- Poor echo window including morbid obesity.
- Age >18 and more than 55 years old
- Patients with previous history of significant valvular diseases,atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)Also: coronary artery bypass grafting (CABG) with maximal use of arterial graftsII-PCI: -Coronary angiography and intervention will be done according to the European guidelines of ACS revascularization. III-CABG: | Procedure or surgery | Group A : Diabetic, Group B: Non diabetic |
Primary outcome
Major adverse cardiac events (MACEs)
Time frame: 12 mounths
Rate of myocardial infarction (MI), Rate of revascularization, Rate of cerebrovascular events"stroke"
1 secondary outcome
In hospital mortality
Time frame: 12mounths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Background: PubMed 28448582Patel SA, Deepa M, Shivashankar R, Ali MK, Kapoor D, Gupta R, Lall D, Tandon N, Mohan V, Kadir MM, Fatmi Z, Prabhakaran D, Narayan KMV. Comparison of multiple obesity indices for cardiovascular disease risk classification in South Asian adults: The CARRS Study. PLoS One. 2017 Apr 27;12(4):e0174251. doi: 10.1371/journal.pone.0174251. eCollection 2017.
- Background: PubMed 31256352Lu H, Tang B, Zhou Y, Xu C, Bundhun PK, Tang Z, Bao H. Short-Term Versus Long-Term Adverse Cardiovascular Outcomes Post Percutaneous Coronary Intervention in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Simple Meta-Analysis. Diabetes Ther. 2019 Aug;10(4):1487-1497. doi: 10.1007/s13300-019-0656-9. Epub 2019 Jun 29.
- (2018) 17:151 Impact of type 2 diabetes mellitus on short- and long-term mortality after coronary artery bypass surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 With Acute Coronary Syndrom, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabab E.A Mashhour, doctor (0201011277166, emadrabab6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACEs) (time frame: 12 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.